With the rapid emergence of diverse locations for performing biological, bio-chemical and chemical assays, the ability to perform these assays in highly decentralized settings under conditions that are not stringently controlled while using personnel with minimal training has become increasingly important. Often, properly trained personnel are either too expensive or simply unavailable. For example, many specialty medical clinics are offering diagnostic tests on-site to allow more rapid diagnosis and treatment. Recent developments have mass-market retailers adding walk-in clinics to the services offered to customers. A means of rapid on-site testing that does not require trained personnel would facilitate these trends. Devices classified as CLIA waived by the US FDA are examples of this level of simplicity of operation. Growing needs for identification of potential bio-agents in remote areas for defense or civilian applications, water quality monitoring and the like have similar requirements. All of these applications may present challenges including: turbid or essentially opaque samples necessitating complex sample preparation methods, high sensitivity and specificity requirements and containment of potentially hazardous samples. In many cases, it is also desirable to test for multiple compounds of interest simultaneously.
There exist assay formats and devices that meet some of the requirements presented above. Lateral flow devices are well established as simple to use and read mechanisms for biological assays. However, these devices typically offer less sensitivity than is desired for many applications. Simultaneous detection of multiple analytes, particularly ones where concentrations of interest vary widely or for which the fundamental assay processes vary is also problematic. Techniques exist which can deal with variable samples but are typically too complex to be used with minimally trained personnel or in harsh environments.
A detection technology that can overcome many of these obstacles utilizes diffractive patterns constructed of binding molecules as a detection element. Current embodiments of this technology, such as those described in United States Patent Publication No. 20050148063 entitled DISPOSABLE REACTION VESSEL WITH INTEGRATED OPTICAL ELEMENTS, and U.S. patent application Ser. No. 11/798,034 entitled AUTOMATED ANALYZER USING LIGHT DIFFRACTION filed May 9, 2007 (US Patent Publication No. 20070264707) claiming priority from U.S. Provisional Patent Application Ser. No. 60/798,719 filed on May 9, 2006, in English, entitled AUTOMATED ANALYZER USING LIGHT DIFFRACTION, (each being incorporated herein by reference in their entirety) while offering many advantages, do not have the simplicity and compactness that are required to meet the needs of highly decentralized testing.
It would therefore be advantageous to provide an economical and easy to use assay chamber for sample assays that provides simple sample acquisition, ease of use, high assay sensitivity and sample containment, and which is readily disposable and can potentially meet the requirements of CLIA waived standards.